EU ombudsman calls for more transparency from AbbVie on Humira
pharmafile | June 10, 2016 | News story | Medical Communications, Research and Development | AbbVie, EMA, EU, Humira, ombudsman
Abbvie continues to withhold details of clinical trials involving the world’s top-selling prescription medicine, Humira (adalimumab), according to the European Union’s ombudsman.
AbbVie have been involved in legal entanglements with the European Medicines Agency (EMA) for several years now, which has seen the pharma company suing the regulatory body to prevent it from releasing data on the drug. O’Reilly became involved at this stage, in an attempt to settle the dispute between the pair. In 2014, the EMA came to a compromise that would see the body publish data via redacted documents, with those redactions proposed by AbbVie.
O’Reilly, however, has released a statement calling for further transparency from AbbVie and the EMA on the issue. Although most of the withheld text was made available to her over the course of her inquiry, there are four redactions, in particular, that O’Reilly considers unjustified.
She says: “I very much welcome EMA’s increasing transparency when it comes to three clinical trial reports on Humira. In the case of the remaining redactions of concern to me, EMA has sought to justify them on grounds of commercial interests. I am asking EMA to reconsider the need for these redactions should it receive new requests for access to these reports.”
While, the ombudsman acknowledges that some information about on-going drug development may justifiably be withheld temporarily, she also indicates that all information about clinical trials, other than the personal data of patients, must ultimately be disclosed.
With many competing drugs presented at EULAR 2016, including new biologics and biosimilars, and its patent expiring in the US in 2016, and in the EU in 2018, AbbVie could be set to take a hit on its blockbuster rheumatoid arthritis drug.
Sean Murray
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